FDA evaluates vision problems with cancer drug Opdivo

The Food and Drug Administration (FDA) is evaluating certain adverse event reports with the cancer drug Opdivo regarding retinal detachment and severe vision loss through its drug safety evaluations program. The biologic was also linked to tumor lysis syndrome, or TLS, a group of metabolic abnormalities that can occur as a treatment of cancer.

The side effects were identified during a review of adverse event reports made to the FDA for New Drug Applications (NDAs) and Biologics License Applications (BLAs). Evaluations are done to determine if there are any new serious adverse events not previously identified during product development, known side effects reported in unusual number, or potential new safety concerns now that the products are being used in the general population.

Beginning no later than 18 months after approval, scientists from the Office of Surveillance and Epidemiology and Office of New Drugs in the Center for Drug Evaluation and Research (CDER) jointly review the relevant data, summarize the findings and, when necessary, develop a plan to further investigate potential new safety issues.

The FDA said it will continue to evaluate the reports of adverse events regarding retinal detachment, severe vision loss and tumor lysis syndrome in patients treated with Opdivo to determine whether regulatory action is required.

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